Nikki A H A Pluymaekers1, Elton A M P Dudink1, Justin G L M Luermans1, Joan G Meeder1, Timo Lenderink1, Jos Widdershoven1, Jeroen J J Bucx1, Michiel Rienstra1, Otto Kamp1, Jurren M Van Opstal1, Marco Alings1, Anton Oomen1, Charles J Kirchhof1, Vincent F Van Dijk1, Hemanth Ramanna1, Anho Liem1, Lukas R Dekker1, Brigitte A B Essers1, Jan G P Tijssen1, Isabelle C Van Gelder1, Harry J G M Crijns1. 1. From the Departments of Cardiology (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.) and Clinical Epidemiology and Medical Technology Assessment (B.A.B.E.), the Cardiovascular Research Institute Maastricht (N.A.H.A.P., E.A.M.P.D., J.G.L.M.L., H.J.G.M.C.), Maastricht University Medical Center, Maastricht, VieCuri Medical Center Noord-Limburg, Venlo (J.G.M.), Zuyderland Medical Center, Heerlen (T.L.), Elisabeth-TweeSteden Hospital, Tilburg (J.W.), Diakonessen Hospital, Utrecht (J.J.J.B.), University of Groningen, Groningen (M.R., I.C.V.G.), VU University Medical Center Amsterdam (O.K.) and Academic Medical Center (J.G.P.T), Amsterdam, Medical Spectrum Twente, Enschede (J.M.V.O.), Amphia Hospital, Breda (M.A.), Antonius Hospital, Sneek (A.O.), Alrijne Hospital, Leiderdorp (C.J.K.), St. Antonius Hospital, Nieuwegein (V.F.V.D.), Haga Teaching Hospital, The Hague (H.R.), St. Franciscus Gasthuis, Rotterdam (A.L.), and Catharina Hospital, Eindhoven (L.R.D) - all in the Netherlands.
Abstract
BACKGROUND:Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with await-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.).
RCT Entities:
BACKGROUND:Patients with recent-onset atrial fibrillation commonly undergo immediate restoration of sinus rhythm by pharmacologic or electrical cardioversion. However, whether immediate restoration of sinus rhythm is necessary is not known, since atrial fibrillation often terminates spontaneously. METHODS: In a multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with hemodynamically stable, recent-onset (<36 hours), symptomatic atrial fibrillation in the emergency department to be treated with a wait-and-see approach (delayed-cardioversion group) or early cardioversion. The wait-and-see approach involved initial treatment with rate-control medication only and delayed cardioversion if the atrial fibrillation did not resolve within 48 hours. The primary end point was the presence of sinus rhythm at 4 weeks. Noninferiority would be shown if the lower limit of the 95% confidence interval for the between-group difference in the primary end point in percentage points was more than -10. RESULTS: The presence of sinus rhythm at 4 weeks occurred in 193 of 212 patients (91%) in the delayed-cardioversion group and in 202 of 215 (94%) in the early-cardioversion group (between-group difference, -2.9 percentage points; 95% confidence interval [CI], -8.2 to 2.2; P = 0.005 for noninferiority). In the delayed-cardioversion group, conversion to sinus rhythm within 48 hours occurred spontaneously in 150 of 218 patients (69%) and after delayed cardioversion in 61 patients (28%). In the early-cardioversion group, conversion to sinus rhythm occurred spontaneously before the initiation of cardioversion in 36 of 219 patients (16%) and after cardioversion in 171 patients (78%). Among the patients who completed remote monitoring during 4 weeks of follow-up, a recurrence of atrial fibrillation occurred in 49 of 164 patients (30%) in the delayed-cardioversion group and in 50 of 171 (29%) in the early-cardioversion group. Within 4 weeks after randomization, cardiovascular complications occurred in 10 patients and 8 patients, respectively. CONCLUSIONS: In patients presenting to the emergency department with recent-onset, symptomatic atrial fibrillation, a wait-and-see approach was noninferior to early cardioversion in achieving a return to sinus rhythm at 4 weeks. (Funded by the Netherlands Organization for Health Research and Development and others; RACE 7 ACWAS ClinicalTrials.gov number, NCT02248753.).
Authors: Salina P Waddy; Allen J Solomon; Adan Z Becerra; Julia B Ward; Kevin E Chan; Chyng-Wen Fwu; Jenna M Norton; Paul W Eggers; Kevin C Abbott; Paul L Kimmel Journal: J Am Soc Nephrol Date: 2020-02-20 Impact factor: 10.121
Authors: Brenton M Wong; Jeffrey J Perry; Wei Cheng; Bo Zheng; Kevin Guo; Monica Taljaard; Allan C Skanes; Ian G Stiell Journal: CJEM Date: 2021-03-14 Impact factor: 2.410